A 2 x 2 randomised controlled trial to evaluate the effectiveness of evidence-based information and communications technology behaviour change tools for weight loss maintenance in overweight/obese adults after clinically significant weight loss

The University of Leeds0 个研究点目标入组 1,600 人开始时间: 2016年12月22日最近更新: 2023年11月13日

适应症

试验速览

2020 Other publications in https://pubmed.ncbi.nlm.nih.gov/32673309/ sleep study results (added 17/07/2020) 2019 Protocol article in https://pubmed.ncbi.nlm.nih.gov/31575569/ protocol (added 15/01/2021) 2020 Other publications in https://pubmed.ncbi.nlm.nih.gov/33447771/ secondary analysis on association between weight variability and cardiometabolic health markers (added 18/01/2021) 2022 Other publications in https://pubmed.ncbi.nlm.nih.gov/35436232/ Usage and effects of web intervention modules (added 19/04/2022) 2022 Other publications in https://pubmed.ncbi.nlm.nih.gov/35006081/ User experience of NoHow Toolkit (added 19/04/2022) 2023 Other publications in https://doi.org/10.1016/j.psychsport.2022.102314 Testing motivational and self-regulatory mechanisms of action on device-measured physical activity in the context of a weight loss maintenance digital intervention: A secondary analysis of the NoHoW trial (added 05/09/2023) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37891654/ Primary and secondary analysis (added 30/10/2023)

•1. Providing written informed consent for study participation prior to any study specific procedures
•2. Aged 18 years or older (no upper limit)
•3. Initial Body Mass Index (prior to weight loss) of =25 kg/m2
•4. Written verification of at least 5% of weight loss in the last 12 months by either a physician, health professional, weight loss counsellor or friend
•5. Access to a smartphone, tablet or computer with Internet access and WiFi at home to receive reminder messages regarding weight recordings, mobile health intervention modules and intervention assessments
•5. Ability to use a standing scale for weight measurements

•1. Inability to give informed consent
•2. Individuals who have lost weight due to illness or surgical procedures, including bariatric procedures
•3. Pregnant or planning to become pregnant in the next 18 months
•4. Mothers who are breastfeeding
•5. Current involvement in other research intervention studies or randomised controlled trials (excluding local health interventions and weight management services)
•6. Inability to follow written material or telephone conversations in the English, Danish or Portuguese language (depending on the centre) that would preclude completion of study questionnaires and use the NoHoW TK
•7. Diagnosis of anorexia nervosa, bulimia nervosa, purging disorder, or screen positive for symptoms of any of these disorders of eating at baseline

发起方